EXHIBIT 10.15
CORPORATE COMPLIANCE AGREEMENT
BETWEEN THE
OFFICE OF INSPECTOR GENERAL
OF THE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
AND
COMMUNITY HEALTH SYSTEMS, INC.
I. PREAMBLE
Community Health Systems, Inc. ("Community Health") hereby enters into
this Corporate Compliance Agreement ("CCA") with the Office of Inspector General
("OIG") of the United States Department of Health and Human Services ("HHS") on
behalf of itself and any and all subsidiary hospitals of Community Health. For
the purposes of the CCA, Community Health and each of its subsidiary hospitals
shall hereinafter individually and collectively be referred to as "CHS."
Community Health enters into this CCA to ensure compliance by CHS and all
employees, contractors and agents of CHS with the requirements of Medicare,
Medicaid and all other Federal health care programs (as defined in 42 U.S.C. ss.
1320a-7b(f) (hereinafter collectively referred to as the "Federal health care
programs"). CHS's compliance with the terms and conditions in this CCA shall
constitute an element of CHS's present responsibility with regard to
participation in the Federal health care programs. Contemporaneously with this
CCA, Community Health is entering into a settlement agreement with the United
States (the "Settlement Agreement"), and this CCA is incorporated by reference
into the Settlement Agreement.
Community Health represents that, prior to this CCA, Community Health
voluntarily established a Corporate Compliance Program which provides, inter
alia, for a Corporate Compliance Officer, various compliance committees, a
compliance training and education program, a confidential reporting hotline, and
auditing and monitoring activities, and which includes various policies and
procedures aimed at ensuring that CHS's participation in the Federal health care
programs conforms to all federal laws, state laws, and Federal health care
program requirements. The present version of Community Health's Corporate
Compliance Program was set forth in a formal document dated April 28, 1999
(hereinafter, the "Corporate Compliance Program").
Pursuant to this CCA, Community Health agrees to operate its Corporate
Compliance Program consistent with the requirements of this CCA and to adopt
or modify any components of the Corporate Compliance Program as needed to be
in compliance with all of the corporate integrity obligations undertaken by
CHS under this CCA.
II. TERM OF THE CCA
The period of the compliance obligations assumed by CHS under this CCA
shall be three (3) years from the effective date of this CCA (unless otherwise
specified). The effective date of this CCA will be the date on which the final
signatory of this CCA executes this CCA.
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III. CORPORATE INTEGRITY OBLIGATIONS
CHS shall comply with the following corporate integrity obligations
and shall ensure that the obligations specified below are incorporated into
or met by the Corporate Compliance Program.
A. CORPORATE COMPLIANCE OFFICER AND COMMITTEE
1. CORPORATE COMPLIANCE OFFICER. Community Health has appointed a
Corporate Compliance Officer. Within 120 days of the effective date of this CCA,
Community Health shall ensure that, pursuant to the Corporate Compliance
Program, the Corporate Compliance Officer (i) will provide regular (at least
quarterly) reports regarding compliance matters directly to the CEO and/or the
Board of Directors of Community Health, and shall be authorized to report to the
Board of Directors at any time; (ii) shall be responsible for developing and
implementing policies, procedures, and practices designed to ensure compliance
with the requirements set forth in this CCA and with the requirements of the
Federal health care programs; and (iii) shall be responsible for monitoring the
day-to-day activities engaged in by CHS to further its compliance objectives as
well as for any reporting obligations created under this CCA. In the event a new
Corporate Compliance Officer is appointed during the term of this CCA, CHS shall
notify OIG, in writing, within fifteen (15) days of such a change.
2. CORPORATE COMPLIANCE WORK GROUP. Community Health has
appointed a Corporate Compliance Work Group. Within 120 days of the effective
date of this CCA, CHS shall ensure that, pursuant to the Corporate Compliance
Plan, (i) the Corporate Compliance Work Group, at a minimum, includes the
Corporate Compliance Officer and any other appropriate officers as necessary to
meet the requirements of this CCA within Community Health's corporate structure
(e.g., senior executives of each major department, such as billing, human
resources, audit, and operations); and (ii) the Corporate Compliance Officer
shall chair the Corporate Compliance Work Group and the Corporate Compliance
Work Group shall support the Corporate Compliance Officer in fulfilling his or
her responsibilities.
3. FACILITY COMPLIANCE CHAIRS AND COMMITTEES. The Corporate
Compliance Program provides for a Facility Compliance Committee and a Facility
Compliance Chair at each CHS hospital. Within 120 days of the effective date of
this CCA, CHS shall ensure that, pursuant to the Corporate Compliance Program,
(i) each CHS hospital has appointed a Facility Compliance Committee and a
Facility Compliance Chair; (ii) the responsibilities of the Facility Compliance
Chair shall include those responsibilities set forth as the "delegated
responsibilities of the Facility Compliance Committees" on pages five and six of
Community Health's Corporate Compliance Program, as adopted on April 28, 1999;
and (iii) the Facility Compliance Committee includes, at a minimum, a Facility
Compliance Chair and any other appropriate officers as necessary to meet the
requirements of this CCA within the hospital's management structure (e.g.,
senior managers of each major department). The Facility Compliance Chairs shall
report to the Corporate Compliance Officer and shall chair the Facility
Compliance Committees, and the Facility Compliance Committees shall support the
Facility Compliance Chairs in fulfilling their duties.
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B. WRITTEN STANDARDS
1. BUSINESS ETHICS AND STANDARDS OF CONDUCT POLICY. Community
Health has developed and implemented a Business Ethics and Standards of Conduct
Policy (the "Ethics and Conduct Policy"). Within 120 days of the effective date
of this CCA, CHS shall amend the Ethics and Conduct Policy to be consistent with
the terms of this CCA and to meet the requirements set forth below. Within 120
days of the effective date of this CCA, the Ethics and Conduct Policy, as
amended, shall be distributed to all employees, all physicians with medical
staff privileges at any CHS hospital, and all contractors and agents of CHS with
direct responsibility for the delivery, billing, or coding of health care
services, (hereinafter collectively referred to as "Covered Persons"). The
Ethics and Conduct Policy, shall, at a minimum, set forth:
a. CHS's commitment to full compliance with all
statutes, regulations, and guidelines applicable to
Federal health care programs, including its
commitment to prepare and submit accurate xxxxxxxx
consistent with Federal health care program
regulations and procedures or instructions otherwise
communicated by appropriate regulatory agencies,
e.g., the Health Care Financing Administration
("HCFA"), and/or their agents;
b. CHS's requirement that all of its Covered Persons shall
be expected to comply with all statutes, regulations,
and guidelines applicable to Federal health care
programs and with CHS's own Policies and Procedures
(including the requirements of this CCA);
c. the requirement that all of CHS's Covered Persons shall
be expected to report suspected violations of any
statute, regulation, or guideline applicable to Federal
health care programs or of CHS's own Policies and
Procedures;
d. the possible consequences to both CHS and Covered
Persons of failure to comply with all statutes,
regulations, and guidelines applicable to Federal health
care programs and with CHS's own Policies and Procedures
or of failure to report such non-compliance; and
e. the right of all Covered Persons to use the Confidential
Disclosure Program, as well as CHS's commitment to
confidentiality and non-retaliation with respect to
disclosures.
CHS shall make the promotion of, and adherence to, the Ethics and Conduct
Policy an element in evaluating the performance of managers, supervisors, and
all other employees.
Within 120 days of the effective date of the CCA, and except as excused
in sections III.C.3-4, below, each Covered Person shall affirm, in writing, that
he or she has received, read,
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understands, and will abide by CHS's Ethics and Conduct Policy. New Covered
Persons shall receive the Ethics and Conduct Policy and shall complete the
required affirmation within one week after becoming a Covered Person or within
120 days of the effective date of the CCA, whichever is later.
CHS will annually review the Ethics and Conduct Policy and will make any
necessary revisions. These revisions shall be distributed within 30 days of
completing such a change. Covered Persons shall affirm on an annual basis that
they have received, read, understand and will abide by the Ethics and Conduct
Policy.
2. POLICIES AND PROCEDURES. Community Health has developed
written Policies and Procedures as part of its Corporate Compliance Program.
Within 120 days of the effective date of this CCA, CHS shall ensure that the
Policies and Procedures of the Corporate Compliance Program (i) address the
operation of CHS's compliance program and its compliance with all federal and
state health care statutes, regulations, and guidelines, including the
requirements of the Federal health care programs; (ii) specifically address, at
a minimum, proper coding for hospital stays; and (iii) include disciplinary
guidelines and methods for employees and other individuals to make disclosures
or otherwise report on compliance issues to CHS management through the
Confidential Disclosure Program required by Section III.E. CHS shall assess and
update as necessary the Policies and Procedures at least annually and more
frequently, as appropriate. A summary of the Policies and Procedures will be
provided to OIG in the first Annual Report. The Policies and Procedures will be
available to OIG upon request.
Within 120 days of the effective date of the CCA, CHS shall ensure that
pursuant to the Corporate Compliance Program, the relevant portions of the
Policies and Procedures, as amended to meet the requirements of this section,
shall be distributed to all members of the Compliance Work Group and of the
Facility Compliance Committees. In addition, within 120 days of the effective
date of this CCA, the relevant portions of the Policies and Procedures, as
amended to meet the requirements of this section, shall be made available to all
appropriate Covered Persons. Compliance staff or supervisors should be available
to explain any and all Policies and Procedures.
C. TRAINING AND EDUCATION
1. GENERAL TRAINING. Within 120 days of the effective date of
this CCA, CHS shall provide at least one (1) hour of training to each Covered
Person (the "General Training"). This General Training shall explain CHS's:
a. Corporate Compliance Agreement requirements;
b. Compliance Program (including the Policies and
Procedures as they pertain to general compliance
issues); and
c. Ethics and Conduct Policy.
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New Covered Persons shall receive the General Training described above
within 30 days of becoming a Covered Person or within 120 days after the
effective date of this CCA, whichever is later. Each Covered Person shall
receive such General Training on an annual basis. All training materials used
for the General Training shall be made available to OIG upon request.
2. SPECIFIC TRAINING. Within 120 days of the effective date of
this CCA, each Covered Person who is a physician or is involved in the
preparation or submission of claims for reimbursement (including, but not
limited to, coding and billing) from any Federal health care program shall
receive at least four (4) hours of training (the "Specific Training") in
addition to the General Training required above. CHS shall ensure that, pursuant
to the Corporate Compliance Program, and as appropriate to the Covered Person's
individual responsibilities, the Specific Training includes a discussion of:
a. the submission of accurate bills for services
rendered to Federal health care program patients;
b. policies, procedures and other requirements applicable
to the documentation of medical records;
c. the personal obligation of each individual involved in
the billing process to ensure that such xxxxxxxx are
accurate;
d. applicable reimbursement statutes, regulations, and
program requirements and directives;
e. the legal sanctions for improper xxxxxxxx; and
f. examples of proper and improper billing practices.
Persons providing the Specific Training must be knowledgeable about the subject
area.
Affected new Covered Persons shall receive the Specific Training within
30 days of becoming a Covered Person or within 120 days of the effective date of
this CCA, whichever is later. If a new Covered Person who is a physician or is
involved in the preparation or submission of claims for reimbursement
(including, but not limited to, coding and billing) from any Federal health care
program has any responsibility for the delivery of patient care, the preparation
or submission of claims, and/or the assignment of procedure codes prior to
completing this Specific Training, a Covered Person who has completed the
Specific Training shall review all of the untrained person's work regarding the
delivery of patient care, the preparation or submission of claims, and the
assignment of procedure codes.
Covered Persons who have received the above-required Specific Training,
or its equivalent, within 12 months prior to the effective date of this CCA are
exempted from the above four (4) hour Specific Training requirement for the
first year of this CCA only. CHS shall maintain records sufficient to support a
listing of those Covered Persons for whom CHS is
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claiming such an exemption as well as the date(s) and topics of the training
received by those Covered Persons.
Every Covered Person who is a physician or is involved in the preparation
or submission of claims for reimbursement (including, but not limited to, coding
and billing) from any Federal health care program shall receive at least four
(4) hours of such Specific Training on an annual basis. All training materials
used for the Specific Training shall be made available to OIG upon request.
3. EXCEPTION FOR PHYSICIANS WITH MEDICAL STAFF PRIVILEGES.
Notwithstanding any other provision of this CCA, CHS shall make the General
Training and the Specific Training, where appropriate, available to all
physicians with medical staff privileges at any CHS hospital, and shall use its
best efforts to encourage their attendance and participation. The Facility
Compliance Officer at each CHS hospital shall maintain records of the percentage
of all physicians with medical staff privileges at his or her hospital who
attend such training.
4. EXCEPTION FOR PRE-EXISTING CONTRACTORS. The term "Pre-Existing
Contractors" shall refer to Covered Persons who are independent contractors with
whom CHS has an existing contract on the effective date of this CCA that has not
been renewed or modified after the effective date of this CCA. Once CHS
renegotiates, modifies, or renews a contract with an existing contractor, that
contractor ceases to be a Pre-Existing Contractor as that term is used for the
purposes of this CCA, and CHS will have full responsibility for the
certification and training compliance obligations as pertain to that contractor.
Notwithstanding any other provision of this CCA, the following are CHS's only
obligations hereunder with respect to training and certification for
Pre-Existing Contractors: (a) CHS shall attempt to renegotiate its contracts
with Pre-Existing Contractors to require such contractors to meet all of the
certification and training requirements of this CCA that apply to such
contractors, and (b) CHS shall make the General Training and the Specific
Training, where appropriate, available to all Pre-Existing Contractors, and
shall use its best efforts to encourage their attendance and participation. The
Facility Compliance Officer at each CHS hospital shall keep a record of all
Pre-Existing Contractors with contracts with his or her hospital who attend such
training.
5. CERTIFICATION. Each individual who is required to attend
training shall certify, in writing, that he or she has attended the required
training. The certification shall specify the type of training received and the
date received. The Facility Compliance Chair for each CHS hospital shall retain
the certifications for all Covered Persons for his or her hospital, along with
the specific course materials utilized. The Corporate Compliance Officer shall
retain the certifications for all Covered Persons not affiliated with a specific
CHS hospital, along with the specific course materials utilized. The
certifications and the materials shall be made available to OIG upon request.
D. REVIEW PROCEDURES
CHS shall retain one or more entities, such as an accounting, auditing or
consulting firms, (hereinafter "Independent Review Organization" or "IRO") to
perform review procedures to
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assist CHS in assessing the adequacy of its billing and compliance practices
pursuant to this CCA. The IROs must have expertise in the billing, coding,
reporting and other requirements of the Federal health care programs from which
CHS seeks reimbursement.
The Independent Review Organizations will conduct two separate
engagements. One will be an analysis of the inpatient ICD-9 and diagnosis
related group ("DRG") coding of each CHS hospital (the "DRG Review") to assist
the CHS and OIG in determining compliance with all applicable statutes,
regulations, and directives/guidance (the "DRG Review"). The second engagement
will determine whether CHS is in compliance with this CCA (the "Compliance
Engagement").
1. DRG REVIEW. Community Health represents that it has engaged,
and will continue to engage for the term of this CCA, an Independent Review
Organization to review the inpatient DRG coding of each CHS hospital. Within 120
days after the effective date of this CCA, CHS shall ensure that, pursuant to
the Corporate Compliance Program, (i) the IRO has expertise in the billing,
coding, reporting and other requirements of the Federal health care programs
from which CHS seeks reimbursement; and (ii) the protocol for the DRG Review
meets the following requirements:
a. each quarter, for each hospital, 40% of all DRG
discharges shall be reviewed;
b. the discharges selected for review must be selected
through random number sampling. To generate the random
sample, CHS or the IRO shall use OIG's Office of Audit
Services Statistical Sampling Software, also known as
"RAT-STATS," which is available through the Internet at
"xxx.xxx.xxx/xxx/xxx/xxxxxxx.xxx];
c. at each hospital, for any billing errors or inaccuracies
found, the coding personnel at that hospital shall
receive training regarding the errors or inaccuracies;
d. if a hospital achieves an error rate of 3% or less,
based on total number of discharges reviewed, then CHS
may elect to skip that hospital in the next quarterly
review, however that hospital shall be included in the
following quarter's review;
e. if a hospital maintains an error rate of 3% or less for
two successive reviews, then CHS may elect to skip that
hospital for the next three quarterly reviews; and
f. in no event will a CHS hospital be subjected to a DRG
review less frequently than once per year.
For the purposes of this CCA, the "error rate" shall be defined as the
gross financial error rate, i.e., the percentage of amounts paid for the sample
discharges that were overpayments (with
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no reduction for underpayments). The 3% error rate threshold, as used in this
section, is solely the criteria for whether CHS may elect to skip a hospital's
quarterly DRG review. Nothing in this section relieves CHS of its responsibility
to correct inaccuracies identified for any claim selected as part of any DRG
review.
CHS shall continue to engage an IRO to perform these quarterly DRG
Reviews for the term of this CCA.
A detailed summary of the reports prepared pursuant to the IRO's DRG
Reviews, including the percentage error rates for each DRG reviewed at each
hospital and a description of the methodologies used, shall be included in each
of CHS's Annual Reports to OIG. The IRO's complete DRG Review reports shall be
maintained by CHS and provided to the OIG upon request.
2. COMPLIANCE ENGAGEMENT. An Independent Review Organization
shall also conduct a Compliance Engagement, that shall provide findings
regarding whether CHS's program, policies, procedures, and operations comply
with the terms of this CCA. The Compliance Engagement shall include section by
section findings regarding the requirements of this CCA. The Compliance
Engagement shall be performed annually and cover each of the one-year periods
beginning on the effective date of this CCA or the anniversary of that date.
Based on the results of the first Compliance Engagement and on the
results of the DRG Reviews for the first year of the term of this CCA, OIG may,
at its sole discretion, relieve CHS of its obligation to retain and IRO to
conduct a Compliance Engagement for the second and third years of this CCA.
A complete copy of the Independent Review Organization's Compliance
Engagement report shall be included in each of CHS's Annual Reports to OIG.
3. VERIFICATION/VALIDATION. In the event that the OIG has
reason to believe that CHS's DRG Review fails to conform materially to its
obligations under the CCA or indicates improper xxxxxxxx not otherwise
adequately addressed in the DRG Review report, and thus determines that it is
necessary to conduct an independent review to determine whether or the extent
to which CHS is complying with its obligations under this CCA, CHS agrees to
pay for the reasonable cost of any such review or engagement by the OIG or
any of its designated agents.
E. CONFIDENTIAL DISCLOSURE PROGRAM
Community Health represents that prior to the effective date of this CCA,
it had established an "Ethics HOTLINE." Within 120 days after the effective date
of this CCA, CHS shall ensure that, pursuant to its Corporate Compliance
Program, it has established a Confidential Disclosure Program, which includes
measures (e.g., the Ethics HOTLINE) to enable employees, contractors, agents or
other individuals to disclose, to the Corporate Compliance Officer or some other
person who is not in the disclosing individual's chain of command, any
identified issues or questions associated with CHS's policies, practices or
procedures with respect to a Federal health care program, believed by the
individual to be inappropriate. CHS shall publicize the existence
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of the Ethics HOTLINE (e.g., e-mail to employees or post hotline number in
prominent common areas).
Pursuant to the Corporate Compliance Program, the Confidential Disclosure
Program shall emphasize a non-retribution, non-retaliation policy, and shall
include a reporting mechanism for anonymous, confidential communication. Upon
receipt of a disclosure, the Corporate Compliance Officer (or designee) shall
gather the information in such a way as to elicit all relevant information from
the disclosing individual. The Corporate Compliance Officer (or designee) shall
make a preliminary good faith inquiry into the allegations set forth in every
disclosure to ensure that he or she has obtained all of the information
necessary to determine whether a further review should be conducted. For any
disclosure that is sufficiently specific so that it reasonably (i) permits a
determination of the appropriateness of the alleged improper practice; and (ii)
provides an opportunity for taking corrective action, CHS shall conduct an
internal review of the allegations set forth in such a disclosure and ensure
that proper follow-up is conducted.
The Corporate Compliance Officer shall maintain a Confidential
Disclosure Log, which shall include a record and summary of each allegation
received, the status of the respective investigations, and any corrective
action taken in response to the investigation.
F. INELIGIBLE PERSONS
1. DEFINITION. For purposes of this CCA, an "Ineligible Person"
shall be any individual or entity who: (i) is currently excluded, suspended,
debarred or otherwise ineligible to participate in the Federal health care
programs; or (ii) has been convicted of a criminal offense related to the
provision of health care items or services and has not been reinstated in the
Federal health care programs after a period of exclusion, suspension, debarment,
or ineligibility.
2. SCREENING REQUIREMENTS. CHS shall not hire or engage as
contractors any Ineligible Person. To prevent hiring or contracting with any
Ineligible Person, CHS shall screen all prospective employees and prospective
contractors prior to engaging their services by: (i) requiring applicants to
disclose whether they are Ineligible Persons, and (ii) reviewing the General
Services Administration's List of Parties Excluded from Federal Programs
(available through the internet at xxxx://xxx.xxxxx.xxx/xxxx) and the HHS/OIG
List of Excluded Individuals/Entities (available through the Internet at
xxxx://xxx.xxxx.xxx/xxx) (these lists will hereinafter be referred to as the
"Exclusion Lists").
3. REVIEW AND REMOVAL REQUIREMENT. Within 120 days of the
effective date of this CCA, CHS will review its list of current employees and
contractors against the Exclusion Lists. Thereafter, CHS will review the list
annually. If CHS has notice that an employee or contractor has become an
Ineligible Person, CHS will remove such person from responsibility for, or
involvement with, CHS's business operations related to the Federal health care
programs and shall remove such person from any position for which the person's
salary or the items or services rendered, ordered, or prescribed by the person
are paid in whole or part, directly or indirectly, by Federal health care
programs or otherwise with Federal funds at least until such time as the person
is reinstated into participation in the Federal health care programs.
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4. PHYSICIANS WITH STAFF PRIVILEGES. Prior to allowing a
physician to begin performing services at a CHS hospital after the effective
date of this CCA, CHS shall screen in the manner described in section III.F.2
above to determine if the physician is an Ineligible Person. Furthermore, CHS
shall review its list of physicians who are allowed to perform services at any
CHS hospital against the Exclusion Lists within 120 days of the effective date
of this CCA and at least annually thereafter. If such a physician is an
Ineligible Person, CHS shall ensure that the physician does not provide, order,
or prescribe any items or services payable in whole or in part by any Federal
health care program. In addition to any other appropriate measures, CHS shall
ensure that any physician who is an Ineligible Person is not "on call" at any
CHS hospital.
5. PENDING CHARGES AND PROPOSED EXCLUSIONS. If CHS has notice
that an employee or contractor is charged with a criminal offense related to any
Federal health care program, or is proposed for exclusion during his or her
employment or contract, CHS shall take all appropriate actions to ensure that
the responsibilities of that employee or contractor do not adversely affect the
quality of care rendered to any patient or resident, or the accuracy of any
claims submitted to any Federal health care program.
G. NOTIFICATION OF PROCEEDINGS
Within 30 days of discovery, CHS shall notify OIG, in writing, of any
ongoing investigation or legal proceeding conducted or brought by a governmental
entity or its agents involving an allegation that CHS has committed a crime or
has engaged in fraudulent activities or any other knowing misconduct. This
notification shall include a description of the allegation, the identity of the
investigating or prosecuting agency, and the status of such investigation or
legal proceeding. CHS shall also provide written notice to OIG within 30 days of
the resolution of the matter, and shall provide OIG with a description of the
findings and/or results of the proceedings, if any.
H. REPORTING
1. REPORTING OF OVERPAYMENTS. If, at any time, CHS identifies or
learns of any billing, coding or other policies, procedures and/or practices
that result in an overpayment, CHS shall notify the payer (e.g., Medicare fiscal
intermediary or carrier) within 30 days of discovering the overpayment and take
remedial steps within 60 days of discovery (or such additional time as may be
agreed to by the payor) to correct the problem, including preventing the
underlying problem and the overpayments from recurring. Notification to the
payor should be done pursuant to a form similar to the Overpayment Refund Form,
provided as Attachment A to this CCA.
2. REPORTING OF MATERIAL DEFICIENCIES. If CHS determines that
there is a material deficiency, CHS shall notify the OIG within 30 days of
making the determination that the material deficiency exists. The report to the
OIG shall include the following information:
a. If the material deficiency results in an overpayment,
the report to the OIG shall be made at the same time as
the notification to the
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payor required in Section H.1, and shall include all of
the information on the Overpayment Refund Form, as well
as:
(i) the payor's name, address, and contact person
where the overpayment was sent; and
(ii) the date of the check and identification number
(or electronic transaction number) on which the
overpayment was repaid;
b. a complete description of the material deficiency,
including the relevant facts, persons involved, and
legal and program authorities;
c. CHS's actions to correct the material deficiency, and
d. any further steps CHS plans to take to address such
material deficiency and prevent it from recurring.
3. DEFINITION OF "OVERPAYMENT." For purposes of this CCA, an
"overpayment" shall mean the amount of money CHS has received in excess of the
amount due and payable under the Federal health care programs' statutes,
regulations or program directives, including carrier and intermediary
instructions.
4. DEFINITION OF "MATERIAL DEFICIENCY." For purposes of this CCA,
a "material deficiency" means anything that involves:
a. a substantial overpayment relating to any Federal
health care program; or
b. a matter that a reasonable person would consider a
potential violation of criminal, civil, or
administrative laws applicable to any Federal health
care program.
A material deficiency may be the result of an isolated event or a series
of occurrences.
IV. NEW BUSINESS UNITS OR LOCATIONS
In the event that CHS purchases or establishes new business units after
the effective date of this CCA, CHS shall notify OIG of this fact within 30 days
of the date of purchase or establishment. This notification shall include the
location of the new operation(s), telephone number, facsimile number, Federal
health care program provider number(s) (if any), and the corresponding payor(s)
(contractor specific) that has issued each provider number. All Covered Persons
at such locations shall be subject to the requirements in this CCA that apply to
new Covered Persons (e.g., completing affirmations and certifications and
undergoing training).
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V. ANNUAL REPORTS
CHS shall submit to OIG Annual Reports with respect to the status and
findings of CHS's compliance activities.
A. FIRST ANNUAL REPORT
The first Annual Report shall include:
1. any change in the name, address, telephone number and position
description of the Corporate Compliance Officer required by
Section III.A.1 from the information provided on pages three
and four of Community Heath's Corporate Compliance Program as
adopted on April 28, 1999 or from the information provided in
Section VI of this CCA;
2. any change in the names and positions of the members of the
Corporate Compliance Work Group required by Section III.A.2
from the information provided on page five of Community
Health's Corporate Compliance Program as adopted on April
28, 1999;
3. a copy of the Ethics and Conduct Policy required by Section
III.B.1;
4. a summary of the Policies and Procedures required by Section
III.B.2;
5. a description of the training programs required by Section
III.C including a description of the targeted audiences and
a schedule of when the training sessions were held, as well
as a list of Covered Persons exempted from the Specific
Training requirements who have received the above-required
Specific Training, or its equivalent, within 12 months
prior to the effective date of this CCA as well as the
date(s) and topics of the training received by those
Covered Persons;
6. a certification by the Corporate Compliance Officer that:
a. all Covered Persons have completed the Ethics and
Conduct Policy affirmation required by Section
III.B.1;
b. the Policies and Procedures required by Section III.B.2
have been developed, are being implemented, and have
been distributed to all members of the Corporate
Compliance Working Group and to all members of the
Facility Compliance Committees;
c. all Covered Persons (other than those exempted and
identified through item 5 of the First Annual Report,
above) have completed the training and executed the
certifications required by Section III.C; and
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d. CHS has complied with its obligations under the
Settlement Agreement: (i) not to resubmit to any
Federal health care program payors any previously
denied claims related to the conduct addressed in the
Settlement Agreement, and its obligation not to
appeal any such denials of claims, and (ii) not to
charge to or otherwise seek payment from federal or
state payors for unallowable costs (as defined in the
Settlement Agreement) and its obligation to identify
and adjust any past charges of unallowable costs;
7. a copy of CHS's policies regarding the Confidential Disclosure
Program required by Section III.H;
8. the identity of the Independent Review Organization(s) engaged
by CHS for the DRG Reviews and a detailed summary of the
reports prepared pursuant to the DRG Reviews, including the
percentage error rates for each DRG reviewed at each hospital
and a description of the methodologies used;
9. the identity of the Independent Review Organization engaged
for the Compliance Engagement and complete copy of the report
prepared pursuant to the Compliance Engagement, including a
copy of the methodology used;
10. CHS's response/corrective action plan to any issues raised by
the Independent Review Organization(s);
11. a summary of material deficiencies, and corresponding
corrective action plans, identified and reported throughout
the course of the previous twelve (12) months pursuant to
III.H;
12. a report of the aggregate overpayments that have been returned
to the Federal health care programs. Overpayment amounts
should be broken down into the following categories: Medicare,
Medicaid (report each applicable state separately), and other
Federal health care programs;
13. a copy of the Confidential Disclosure Log required by Section
III.E;
14. a description of any personnel actions (other than hiring)
taken by CHS as a result of the obligations in Section III.F,
and the name, title, and responsibilities of any person that
falls within the ambit of Section III.F.4, and the actions
taken in response to the obligations set forth in that
Section;
15. a summary describing any ongoing investigation or legal
proceeding conducted or brought by a governmental entity
involving an allegation that
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CHS has committed a crime or has engaged in fraudulent
activities, which have been reported pursuant to Section
III.G. The statement shall include a description of the
allegation, the identity of the investigating or prosecuting
agency, and the status of such investigation, legal proceeding
or requests for information; and
16. a list of all of CHS's locations (including locations and
mailing addresses), the corresponding name under which each
location is doing business, the corresponding telephone
numbers and facsimile numbers, each location's Federal health
care program supplier number(s), and the name, address, and
telephone number of the payor (specific contractor) that
issued each provider identification number.
B. SECOND AND THIRD ANNUAL REPORTS
The second and third Annual Reports shall include the following:
1. any change in the identity or position description of the
Corporate Compliance Officer or the members of the
Corporate Compliance Working Group described in Section
III.A;
2. a certification by the Corporate Compliance Officer that:
a. all Covered Persons have completed the annual Ethics and
Conduct Policy affirmation required by Section III.B.1;
b. all Covered Persons have completed the training and
executed the certification required by Section III.C; and
c. CHS has complied with its obligations under the
Settlement Agreement: (i) not to resubmit to any Federal
health care program payors any previously denied claims
related to the conduct addressed in the Settlement
Agreement, and its obligation not to appeal any such
denials of claims, and (ii) not to charge to or otherwise
seek payment from federal or state payors for unallowable
costs (as defined in the Settlement Agreement) and its
obligation to identify and adjust any past charges of
unallowable costs;
3. notification of any changes or amendments to the Policies and
Procedures required by Section III.B and the reasons for such
changes (E.G., change in contractor policy);
4. the identity of the Independent Review Organization(s)
engaged by CHS for the DRG Reviews and a detailed summary
of the reports prepared pursuant to the DRG Reviews,
including the percentage error rates for each DRG reviewed
at each hospital and a description of the
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methodologies used, and a complete copy of the report
prepared pursuant to the Compliance Engagement (if
required), including a copy of the methodology used;
5. CHS's response/corrective action plan to any issues raised by
the Independent Review Organization(s);
6. a summary of material deficiencies, and corresponding
corrective action plans, identified and reported throughout
the course of the previous twelve (12) months pursuant to
III.H;
7. a report of the aggregate overpayments that have been returned
to the Federal health care programs. Overpayment amounts
should be broken down into the following categories: Medicare,
Medicaid (report each applicable state separately) and other
Federal health care programs;
8. a copy of the Confidential Disclosure Log required by Section
III.E;
9. a description of any personnel actions (other than hiring)
taken by CHS as a result of the obligations in Section III.F,
and the name, title, and responsibilities of any person that
falls within the ambit of Section III.F.4, and the actions
taken in response to the obligations set forth in that
Section;
10. a summary describing any ongoing investigation or legal
proceeding conducted or brought by a governmental entity
involving an allegation that CHS has committed a crime or
has engaged in fraudulent activities, which have been
reported pursuant to Section III.G. The statement shall
include a description of the allegation, the identity of
the investigating or prosecuting agency, and the status of
such investigation, legal proceeding or requests for
information;
11. a description of all changes to the most recently provided
list (as updated) of CHS's locations (including locations
and mailing addresses), the corresponding name under which
each location is doing business, the corresponding phone
numbers and fax numbers, each location's Federal health
care program provider identification number(s), and the
payor (specific contractor) that issued each provider
identification number,
C. CERTIFICATIONS
All Annual Reports shall include a certification by the Corporate
Compliance Officer under penalty of perjury, that: (1) CHS is in compliance
with all of the requirements of this CCA, to the best of his or her
knowledge; and (2) the Corporate Compliance Officer has reviewed the Report
and has made reasonable inquiry regarding its content and believes that, upon
such inquiry, the information is accurate and truthful.
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D. ANNUAL REPORT DUE DATES
The first Annual Report shall be received by the OIG no later than one
year and 30 days after the effective date of this CCA. The second and third
Annual Reports shall be received by the OIG no later than two years and 30
days, and three years and 30 days, respectively, after the effective date of
this CCA.
VI. NOTIFICATIONS AND SUBMISSION OF REPORTS
Unless otherwise stated in writing subsequent to the effective date of
this CCA, all notifications and reports required under this CCA shall be
submitted to the entities listed below:
OIG:
Civil Recoveries Branch - Compliance Unit
Office of Counsel to the Inspector General
Office of Inspector General
U.S, Department of Health and Human Services
Xxxxx Building, Room 5527
000 Xxxxxxxxxxxx Xxxxxx, XX
Xxxxxxxxxx, XX 00000
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
CHS:
Xxxxxx X. Xxxxxxxxxxx
Corporate Compliance Officer
Community Health Systems, Inc.
000 Xxxxxxxx Xxxx, Xxxxx 000
Xxxxxxxxx, XX 00000-0000
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
VII. OIG INSPECTION, AUDIT AND REVIEW RIGHTS
In addition to any other rights OIG may have by statute, regulation, or
contract, OIG or its duly authorized representative(s), may examine CHS's books,
records, and other documents and supporting materials and/or conduct an on-site
review of any of CHS's locations for the purpose of verifying and evaluating:
(a) CHS's compliance with the terms of this CCA; and (b) CHS's compliance with
the requirements of the Federal health care programs in which it participates.
The documentation described above shall be made available by CHS to OIG or its
duly authorized representative(s) at all reasonable times for inspection, audit
or reproduction. Furthermore, for purposes of this provision, OIG or its duly
authorized representative(s) may interview any of CHS's employees, contractors,
or agents who consent to be interviewed at the individual's place of business
during normal business hours or at such other place and time as may be mutually
agreed upon between the individual and OIG. CHS agrees to assist OIG in
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contacting and arranging interviews with such individuals upon OIG's request.
CHS's employees may elect to be interviewed with or without a representative of
CHS present.
VIII. DOCUMENT AND RECORD RETENTION
Pursuant to the Corporate Compliance Program, CHS shall maintain for
inspection all documents and records relating to reimbursement from the
Federal health care programs or to compliance with this CCA, for four (4)
years (or longer if otherwise required).
IX. DISCLOSURES
Subject to HHS's Freedom of Information Act ("FOIA") procedures, set
forth in 45 C.F.R. Part 5; the OIG shall make a reasonable effort to notify CHS
prior to any release by OIG of information submitted by CHS pursuant to its
obligations under this CCA and identified upon submission by CHS as trade
secrets, commercial or financial information and privileged and confidential
under the FOIA rules. CHS shall refrain from identifying any information as
trade secrets, commercial or financial information and privileged and
confidential that does not meet the criteria for exemption from disclosure under
FOIA.
X. BREACH AND DEFAULT PROVISIONS
CHS is expected to fully and timely comply with all of the obligations
herein throughout the term of this CCA or other time frames herein agreed to.
A. STIPULATED PENALTIES FOR FAILURE TO COMPLY WITH CERTAIN OBLIGATIONS
As a contractual remedy, Community Health and OIG hereby agree that
failure to comply with certain obligations set forth in this CCA may lead to the
imposition of the following monetary penalties (hereinafter referred to as
"Stipulated Penalties") in accordance with the following provisions,
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on
the day after the date the obligation became due) for each day, beginning 120
days after the effective date of this CCA and concluding at the end of the term
of this CCA, CHS fails to have in place any of the following:
a. a Corporate Compliance Officer;
b. a Corporate Compliance Working Group;
c. Facility Compliance Chairs and Facility Compliance
Committees at each CHS hospital;
d. a written Ethics and Conduct Policy;
e. written Policies and Procedures;
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f. a training program, and
g. a Confidential Disclosure Program;
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on
the day after the date the obligation became due) for each day CHS fails to meet
any of the deadlines to submit the Annual Reports to the OIG.
3. A Stipulated Penalty of $2,000 (which shall begin to accrue on
the date the failure to comply began) for each day:
a. after CHS hires or enters into a contract with an
Ineligible Person after that person has been listed by a federal agency as
excluded, debarred, suspended or otherwise ineligible for participation in the
Medicare, Medicaid or any other Federal health care program (as defined in 42
U.S.C. ss. 1320a-7b(f) (this Stipulated Penalty shall not be demanded for any
time period during which CHS can demonstrate that it did not discover the
person's exclusion or other ineligibility after making a reasonable inquiry (as
described in Section III.F) as to the status of the person);
b. CHS employs or contracts with an Ineligible Person and that
person: (i) has responsibility for, or involvement with, CHS's business
operations related to the Federal health care programs or (ii) is in a position
for which the person's salary or the items or services rendered, ordered, or
prescribed by the person are paid in whole or part, directly or indirectly, by
Federal health care programs or otherwise with Federal funds (this Stipulated
Penalty shall not be demanded for any time period during which CHS can
demonstrate that it did not discover the person's exclusion or other
ineligibility after making a reasonable inquiry (as described in Section III.F)
as to the status of the person); or
c. a physician who performs services at any CHS hospital who
is an Ineligible Person provides, orders, or prescribes any items or services
payable in whole or in part by any Federal health care program to CHS (this
Stipulated Penalty shall not be demanded for any time period during which CHS
can demonstrate that it did not discover the physician's exclusion or other
ineligibility after making a reasonable inquiry (as described in section III.F.)
as to the status of the physician).
4. A Stipulated Penalty of $1,500 (which shall begin to accrue on
the date the CHS fails to grant access) for each day CHS fails to grant access
to the information or documentation as required in Section VII of this CCA.
5. A Stipulated Penalty of $1,000 (which shall begin to accrue 10
days after the date that OIG provides notice to CHS of the failure to comply; no
penalties shall be imposed under this section X.A.5 if CHS complies fully and
adequately with its obligations within 10 days of the OIG's notice of the
failure to comply) for each day CHS fails to comply fully and adequately with
any obligation of this CCA. In its notice to CHS, the OIG shall state the
specific grounds for its determination that CHS has failed to comply fully and
adequately with the CCA obligation(s) at issue.
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B. PAYMENT OF STIPULATED PENALTIES
1. DEMAND LETTER. Upon a finding that CHS has failed to comply
with any of the obligations described in Section X-A and determining that
Stipulated Penalties are appropriate, OIG shall notify CHS by personal service
or certified mail of (a) CHS's failure to comply; and (b) the OIG's exercise of
its contractual right to demand payment of the Stipulated Penalties (this
notification is hereinafter referred to as the "Demand Letter").
Within fifteen (15) days of the date of the Demand Letter, CHS shall
either (a) cure the breach to the OIG's satisfaction and pay the applicable
stipulated penalties: or (b) request a hearing before an HHS administrative law
judge ("ALJ") to dispute the OIG' s determination of noncompliance, pursuant to
the agreed upon provisions set forth below in Section X.D. In the event CHS
elects to request an ALJ hearing, the Stipulated Penalties shall continue to
accrue until CHS Cures, to the OIG's satisfaction, the alleged breach in
dispute, Failure to respond to the Demand Letter in one of these two manners
within the allowed time period shall be considered a material breach of this CCA
and shall be grounds for exclusion under Section X.C.
2. TIMELY WRITTEN REQUESTS FOR EXTENSIONS. CHS may submit a
timely written request for an extension of time to perform any act or file any
notification or report required by this CCA. Notwithstanding any other provision
in this Section, if OIG grants the timely written request with respect to an
act, notification, or report, Stipulated Penalties for failure to perform the
act or file the notification or report shall not begin to accrue until one day
after CHS fails to meet the revised deadline set by the OIG. Notwithstanding any
other provision in this Section, if OIG denies such a timely written request,
Stipulated Penalties for failure to perform the act or file the notification or
report shall not begin to accrue until two (2) business days after CHS receives
OIG's written denial of such request. A "timely written request" is defined as a
request in writing received by OIG at least five (5) business days prior to the
date by which any act is due to be performed or any notification or report is
due to be filed.
3. FORM OF PAYMENT. Payment of the Stipulated Penalties shall be
made by certified or cashier's check, payable to "Secretary of the Department of
Health and Human Services," and submitted to OIG at the address set forth in
Section VI.
4. INDEPENDENCE FROM MATERIAL BREACH DETERMINATION. Except as
otherwise noted, these provisions for payment of Stipulated Penalties shall not
affect or otherwise set a standard for the OIG's determination that CHS has
materially breached this CCA, which decision shall be made at the OIG's
discretion and governed by the provisions in Section X.C, below.
C. MONETARY PENALTY FOR MATERIAL BREACH OF THIS CCA
1. DEFINITION OF "MATERIAL BREACH." A material breach of this CCA
means:
a. a failure by CHS to report a material deficiency,
take corrective action and pay the appropriate
refunds, as provided in Section III.H;
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b. repeated or flagrant violations of the obligations under
this CCA, including, but not limited to, the obligations
addressed in Section X.A of this CCA;
c. a failure to respond to a Demand Letter concerning the
payment of Stipulated Penalties in accordance with
Section X.B above; or
d. a failure to retain and use an Independent Review
Organization for review purposes in accordance with
Section III.D.
2. NOTICE OF MATERIAL BREACH AND INTENT TO COLLECT MATERIAL
BREACH PENALTY. Community Health and OIG agree that a material breach of this
CCA by CHS constitutes grounds for OIG to impose an enhanced stipulated penalty
that is separate and apart from the Stipulated Penalties described in Sections
X.A-B, above. This monetary penalty (hereinafter referred to as the "Material
Breach Penalty") shall be $25,000 per day. Upon a determination by OIG that CHS
has materially breached this CCA and that a Material Breach Penalty should be
imposed, the OIG shall notify CHS by certified mail of (a) CHS's material
breach; and (b) OIG's intent to exercise its contractual right to impose the
Material Breach Penalty (this notification is hereinafter referred to as the
"Notice of Material Breach").
3. OPPORTUNITY TO CURE. CHS shall have thirty five (35) days from
the date of the Notice of Material Breach to demonstrate to the OIG's
satisfaction that:
a. CHS is in full compliance with this CCA;
b. the alleged material breach has been cured; or
c. the alleged material breach cannot be cured within the
35-day period, but that: (i) CHS has begun to take
action to cure the material breach, (ii) CHS is pursuing
such action with due diligence, and (iii) CHS has
provided to OIG a reasonable timetable for curing the
material breach.
4. PENALTY LETTER. If at the conclusion of the thirty five (35)
day period, CHS fails to satisfy the requirements of Section X.C.3, OIG may
impose the Material Breach Penalty on CHS, and the Material Breach Penalty shall
begin to accrue on that day. OIG will notify CHS in writing of its determination
to impose the Material Breach Penalty (this letter shall be referred to
hereinafter as the "Material Breach Penalty Letter"). Within fifteen (15) days
of receipt of the Material Breach Penalty Letter, CHS shall either: (a) cure the
material breach to OIG's satisfaction and pay the applicable Material Breach
Penalty; or (b) request a hearing before an HHS administrative law judge ("ALJ")
to dispute OIG's determination of material breach, pursuant to the agreed upon
provisions set forth below in Section X.D.
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D. DISPUTE RESOLUTION
1. REVIEW RIGHTS. Upon OIG's delivery to CHS of its Demand Letter
or of its Material Breach Penalty Letter, and as an agreed-upon contractual
remedy for the resolution of disputes arising under the obligation of this CCA,
CHS shall be afforded certain review rights comparable to the ones that are
provided in 42 U.S.C. ss. 1320a-7(f) and 42 C.F.R. Part 1005 as if they applied
to the Stipulated Penalty or Material Breach Penalty sought pursuant to this
CCA. Specifically, OIG's determination to demand payment of a Stipulated Penalty
or of a Material Breach Penalty shall be subject to review by an ALJ and, in the
event of an appeal, the Departmental Appeals Board ("DAB"), in a manner
consistent with the provisions in 42 C.F.R. xx.xx. 1005.2-1005.21.
Notwithstanding the language in 42 C.F.R. ss. 1005.2(c), the request for a
hearing involving a Stipulated Penalty or a Material Breach Penalty shall be
made within fifteen (15) days of the date of the Demand Letter or the Material
Breach Penalty Letter.
2. STIPULATED PENALTIES REVIEW. Notwithstanding any provision of
Title 42 of the United States Code or Chapter 42 of the Code of Federal
Regulations, the only issues in a proceeding for stipulated penalties under this
CCA shall be (a) whether CHS was in full and timely compliance with the
obligations of this CCA for which OIG demands payment; and (b) the period of
noncompliance, CHS shall have the burden of proving its full and timely
compliance and the steps taken to cure the noncompliance, if any. If the ALJ
finds for OIG with regard to a finding of a breach of this CCA and orders CHS to
pay Stipulated Penalties, such Stipulated Penalties shall become due and payable
20 days after the ALJ issues such a decision notwithstanding that CHS may
request review of the ALJ decision by the DAB,
3. MATERIAL BREACH REVIEW. Notwithstanding any provision of Title
42 of the United States Code or Chapter 42 of the Code of Federal Regulations,
the only issues in a proceeding regarding imposition of a Material Breach
Penalty shall be: (a) whether CHS was in material breach of this CCA; (b)
whether such breach was continuing on the date of the Material Breach Penalty
Letter, (c) the number of days that CHS was in material breach of this CCA; and
(d) whether the alleged material breach could not have been cured within the 35
day period, but that (i) CHS had begun to take action to cure the material
breach within that period, (ii) CHS has pursued and is pursuing such action with
due diligence, and (iii) CHS provided to OIG within that period a reasonable
timetable for curing the material breach.
If the ALJ finds for OIG with regard to a finding of a material breach of
this CCA and orders CHS to pay a Material Breach Penalty, such Material Breach
Penalty shall become due and payable 20 days after the ALJ issues such a
decision notwithstanding that CHS may request review of the ALJ decision by the
DAB.
4. FINALITY OF DECISION. The review by an ALJ or DAB provided for
above shall not be considered to be an appeal right arising under any statutes
or regulations. Consequently, the parties to this CCA agree that the DAB's
decision (or the ALJ's decision if not appealed) shall be considered final for
all purposes under this CCA and CHS agrees to waive any right it may have to
appeal the decision administratively, judicially or otherwise seek review by any
court or other adjudicative forum.
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XI. EFFECTIVE AND BINDING AGREEMENT
Consistent with the provisions in the Settlement Agreement pursuant to
which this CCA is entered, and into which this CCA is incorporated, CHS and OIG
agree as follows:
A. This CCA shall be binding on the successors, assigns, and
transferees of Community Health;
B. This CCA shall become final and binding on the date the final
signature is obtained on the CCA;
C. Any modifications to this CCA shall be made with the prior written
consent of the parties to this CCA; and
D. The undersigned Community Health signatories represent and warrant
that they are authorized to execute this CCA. The undersigned OIG signatory
represents that he is signing this CCA in his official capacity and that he is
authorized to execute this CCA.
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ON BEHALF OF COMMUNITY HEALTH SYSTEMS, INC.
----------------------------------- --------------------------------
XXXXX X. XXXXX DATE
Chief Executive Officer
Community Health Systems, Inc.
----------------------------------- --------------------------------
XXXXXX X. XXXXXXX, ESQ. DATE
Vice President and General Counsel
Community Health Systems, Inc.
----------------------------------- --------------------------------
XXXXXXX XXXXXX, ESQ. DATE
Xxxxx, Xxxxx, Xxxxxxx & Xxxxxxxx
Counsel for Community Health Systems, Inc.
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ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL
OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES
----------------------------------- --------------------------------
XXXXX XXXXXX DATE
Assistant Inspector General for Legal Affairs
Office of Inspector General
U. S. Department of Health and Human Services
